CN105592830B

CN105592830B - Carrying system for an article to be worn on the body and method for producing the same

Info

Publication number: CN105592830B
Application number: CN201480055689.6A
Authority: CN
Inventors: N.戈尔德贝格; M.赫贝茨; O.库贝; R.尼滕维尔姆; H.瓦尔特
Original assignee: F Hoffmann La Roche AG
Current assignee: F Hoffmann La Roche AG
Priority date: 2013-10-10
Filing date: 2014-10-09
Publication date: 2020-04-10
Anticipated expiration: 2034-10-09
Also published as: PL3054908T3; RU2016117906A; US10542936B2; WO2015052288A1; SI3054908T1; US20160213322A1; RU2016117906A3; RU2668200C2; EP3054908A1; CA2926370C; EP3054908B1; DK3054908T3; CA2926370A1; CN105592830A; ES2675006T3

Abstract

The invention relates to a carrier system for an article (12) to be worn on the body, comprising a flexible carrier adhesive layer (18) comprising a sheet-like carrier layer (30) and an adhesive layer (32) applied to the underside of the carrier layer, which adhesive layer adheres to the skin (14) of a body part (16) when pressure is applied thereto, the adhesive layer comprising a pressure sensitive adhesive (34), and further comprising a rigid mounting platform (20) on the upper side of the carrier layer (30) remote from the skin. According to the invention, the joining region (36) of the mounting platform (20) is permanently joined to the upper side of the carrier layer (30) by a structural adhesive connection (38) comprising a structural adhesive (40).

Description

Carrying system for an article to be worn on the body and method for producing the same

Technical Field

The invention relates to a carrier system for body-worn articles, in particular medical devices with a flexible carrier adhesive layer, comprising a sheet-like carrier layer and on the underside thereof an adhesive layer which comprises a pressure-sensitive adhesive and adheres to the skin of a body part by contact pressure, and a rigid assembly platform which is arranged in particular on the upper side of the carrier layer remote from the skin. The invention further relates to a method for producing the carrying system and a specific method for using the carrying system.

Background

The medical devices and applications generally require the highest possible degree of quality and reliability. The materials used for this type must meet a wide variety of requirements: they need to be, for example, biocompatible and/or inert, and corrosion and heat resistant, and they also need to operate flawlessly over a very wide range of conditions. This means that such systems and their manufacturing methods are subject to stringent requirements. As with all other materials used directly on the human body in the medical field, adhesives must not only comply with very high quality standards, but also with various regulatory provisions; this also applies to the production operation as a whole.

In the field of dynamic blood glucose monitoring (CGM), Insulin Delivery Systems (IDS) and electroencephalogram (EEG) detection, a biomedical engineering solution is known to connect the carrier adhesive layer and the instrument by ultrasonic welding. The wearing period can be up to 4 days, in some cases even 5 days, with a "standard adhesive layer" comprising soft fabric. The standard cling layer has an added pressure sensitive adhesive maximum of less than 80 g/m². Due to long wear or high loads on the body, the adhesive layer gradually starts to separate from the edge. In an attempt to obtain a patient wearing for a long period of time, the adhesive layer must in particular be constantly reapplied or over-applied, otherwise the adhesive layer may fail prematurely. The reason for this early failure is not only that standard adhesive layers are used, which are not designed for such long wear; and also in the joining technique of ultrasonic welding. This involves the precise input of high heat to slightly melt the carrier material (temperature greater than 130 ℃) which comprises plastic. But this results in some local decomposition of the carrier material, thereby reducing the effectiveness of the adhesive surface and resulting in a build-up of pressure inside the adhesive film. This results in the adhesive layer separating from the body in view of the viscoelastic system involved. As a result, the effective adhesion surface of the adhesive layer to the body is weakened. This is often the case in the area under the medical device, andin view of the envisaged function, it is actually considered that it should adhere particularly well to the skin, for example the contact attachment of skin electrodes.

EP-a 1923081 discloses an infusion device for insulin comprising a catheter head which can be attached to the skin by means of an adhesive layer and has on its upper side a connector which is releasably and rotatably insertable into an insulin pump, wherein the complete attachment to the body is established only on a direct adhesive attachment to the skin of the peripheral region of the insulin pump extending beyond the adhesive layer. Unspecified skin compatible adhesives are said to be utilized. While the result of locating the insulin pump properly donned on the body is obtained, a secure attachment does require the use and disposal of additional skin adhesive at the point of use.

US 2011/257997 a1 describes a device for treating a patient, which device comprises a two-part housing comprising a base part for attachment to the skin and an upper part which is movable and attachable thereto, the two parts being releasably connected or optionally adhered together by a positive mechanical form fit. As a bonding area, only molded protruding structures are disclosed, resulting in considerable expense and inconvenience in production and assembly.

Disclosure of Invention

Starting from this, the invention sets out to solve the problems of further improving the prior art systems and processes and of providing a high level of non-slip performance over a long time, and a reliable level of wearability, and having a simplified, easy to manufacture, uncomplicated to attach design.

This problem is solved by the combination of features specified in the independent claims. Advantageous embodiments and refinements of the invention will be apparent from the dependent claims.

The concept of the invention is to attach the item to be worn in such a way that the pressure-sensitive adhesive layer of the adhesive layer is damaged as little as possible. Accordingly, the present invention provides a joint or structural zone of the assembly platform, securely connected to the upper side of the carrier layer by a structural (construction) type adhesive bond comprising a structural adhesive. This strong bond is due to the fact that structural adhesion can only be destroyed destructively, whereas pressure sensitive adhesive adhesion is in principle reversible.

Structural adhesives are in principle an alternative to adhesives used for joining connections and thus gain significant importance in ensuring stability and/or the function of the component parts. Structural adhesive bonds and/or structural adhesives are also referred to herein. The rule of thumb is that structural adhesive bonds have a value of greater than 2N/mm²The shear strength of (2). In contrast, a pressure-sensitive adhesive, as an adhesive, provides viscoelastic adhesion and direct contact adhesion to various surfaces in a solvent-free state and particularly at room temperature, in such a manner that the surface of the adhered portion is pressed downward to thereby bring about some form of wetting and obtain sufficient adhesion.

The structural adhesive bond provided by the present invention between the assembly platform/substrate and the adhesive layer ensures that the pressure sensitive adhesive layer on the adhesive layer (which establishes a bond with the body) is not damaged. As a result, the large effective adhesion area makes it possible to adhere the entire force with which the worn article is held in place. Due to the maintained flexibility of the carrier material, a lower level of shear strength between the body and the adhesive layer is obtained. Edge separation of the adhesive layer is also reduced and results are achieved for longer wear periods without system failure. The restriction to the user under ordinary daily conditions is minimized and the wearing comfort is improved to ensure better acceptance.

The carrier adhesive layer is advantageously protected by a release liner, preferably removable in the manner of a protruding sheet, which covers the adhesive side of the adhesive layer before application. The release liner may also be constructed in two or more parts.

In a further advantageous embodiment, the carrier layer upper side is attached flatly by means of a structural adhesive on the underside of the assembly platform joining area, whereby a platform attachment is obtained which is simple in assembly form and reliable without being decomposable without damaging the pressure-sensitive adhesive layer.

Preferably, the carrier layer comprises a sheet material or a textile material or a foamed material or a combination thereof, whereby a sheet-like configuration of an irregular skin contour is possible.

In order to obtain high flexibility and good water vapour permeability, the carrier layer advantageously comprises a (single-or multi-layer) thermoplastic, preferably a microporous sheet.

In order to be sufficiently stretchable, the carrier layer should have a thickness of less than 10N/mm²Preferably less than 5N/mm²Maximum modulus of elasticity of (d).

Advantageously, the adhesive layer has a pressure sensitive adhesive application of 80 to 120 g/m²Preferably 100 to 110 g/m². Background is because human skin has a high level of surface roughness (due to, for example, dead skin debris, wrinkles, etc.), and adhesives are able to penetrate (flow) into deeper layers of the skin. Increasing the amount of binder to more than 80 g/m²And accordingly helps to improve the level and length of adhesion to human skin.

In a further advantageous embodiment, the adhesive layer is formed from a pressure sensitive adhesive based on acrylates, silicones, rubbers, thermoplastic elastomers, hydrogels, polyurethanes, polysiloxanes, vinyl acetate or mixtures thereof. An acrylate-vinyl acetate copolymer is preferably used as the pressure-sensitive adhesive.

In view of the need for longer wearing periods and the long-lasting good adhesion to the skin, as well as the painless, residue-free detachment, breathability and thus the moisture permeability (MVTR, "moisture vapor transmission rate") become decisive parts. This water vapour permeability can be determined in accordance with DIN EN 13726-2 at a temperature of 37 ℃ and an ambient humidity of 18%. Advantageously, the support layer and/or the adhesive layer of the adhesive layer have a moisture permeability value of more than 400 g/m in 24 hours²Moisture vapor transmission rate of (c).

To obtain a high level of strength, it is advantageous if the structural adhesive bond comprises a structural adhesive based on cyanoacrylate, epoxy or polyurethane adhesives.

Due to the long duration of wear on the body, pressure sensitive adhesives and structural adhesives should have biocompatible components that are medically approved.

Advantageously, the assembly platform is shaped by means of a plastic mould, preferably made of polycarbonate.

The invention also provides a medical instrument comprising the bearing system.

The problem initially defined is solved by a method of manufacturing a carrier system for a body worn article during manufacture, the method comprising the steps of:

-providing a carrier adhesive layer, preferably as part of a die cut, comprising a carrier layer, an adhesive layer and a release liner,

applying a structural adhesive as an adhesive bead to the joint area of the assembly platform,

-contacting the engagement area with the upper side of the carrier-adhesive layer facing away from the skin to form a structural adhesive bond.

In order to obtain a structural material bond, it is advantageous for the assembly platform to press it against the adhesive layer during curing of the structural adhesive.

Additional improvements can be obtained when the structural adhesive is dried/cured in a reinforcing manner (optionally by irradiation after contact) in order to achieve full joint strength.

A further aspect of the invention relates to a method of use of the inventive carrier system for at least one application from the group of:

-perceptually monitoring and/or capturing a physical parameter,

-administering active principles, in particular insulin to or through the skin,

-providing a body entrance or a body exit,

-wearing a body hanger.

Drawings

The invention will now be described in more detail with reference to exemplary embodiments, which are schematically represented in the drawings, in which:

figure 1 shows a perspective view of a carrier system with a medical device for pressure sensitive adhesive attachment to skin,

figure 2 shows the load carrying system with the assembled platform in a representation corresponding to figure 1,

figure 3 shows a cross-sectional view along 3-3 of the carrying system in figure 2 in a state of adhesion to the skin, an

Fig. 4 shows an enlarged detail of fig. 3.

Detailed Description

The carrier system 10 shown in the drawings is designed for the pressure-sensitive adhesive attachment of a long-term-use diagnostic medical device 12 to the skin 14 of a body part 16 and comprises for this purpose a carrier adhesive layer 18 and a rigid assembly platform 20 arranged on its upper side remote from the skin. The self-adhesive underside carrying the adhesive layer 18 is covered before use by a two-part release liner 22, the release liner 22 being readily removable by a projecting tab 24.

As is evident from fig. 1 and 2, the assembly platform 20 makes it possible to assemble the instrument 12 by means of a form-fitting device 26. The permanently attached assembly platform 20 may also be an integral part of the instrument 12. The instrument and/or appliance may be a diagnostic measurement system, such as continuous blood glucose monitoring, a sensor or a delivery device for a drug, for example in the form of an insulin pump; or may additionally contain electronic sub-components such as Radio Frequency Identification (RFID) chips. Further possible applications include organ monitoring, such as glomerular filtration rate for examination of renal function, or performing lactate tests.

In the illustrated embodiment, the assembly platform is molded from a sheet-type plastic, such as polycarbonate. Direct entry and/or exit to the skin is provided by the holes 28 in the assembly platform 20 and the area of the adhesive layer beneath them.

As best seen in fig. 3 and 4, the carrier adhesive layer 18 comprises a sheet-like flexible carrier layer 30, and an adhesive layer 32 on the underside of the carrier layer, the adhesive layer 32 comprising a pressure sensitive adhesive 34 and adhering to the skin 14 by contact pressure. The rigid assembly platform 20 is permanently fastened in a structural area 36 of the upper side of the carrier layer 30 facing away from the skin, the structural area 36 being configured as a lower landing zone by a construction or structural adhesive 38 comprising a structural adhesive 40.

A requirement for the skin-attachable load-bearing adhesive layer 18 core is that the adhesive used should be skin-compatible and/or biocompatible, e.g. according to DIN ISO 10993. This also includes, in particular, very low residual monomer contents in order to rule out any cytotoxic or skin-irritating effects. From the point of view of long-term use, for example over a period of up to seven days, further requirements become important, which include, in principle, the requirement that the adhesive layer does not detach or slide off even in everyday situations, for example during exercise, shower, bath or sauna, and does not obstruct the carrier in any way-and further that there should be no pressure and no disturbance of the microcirculation of the skin-and furthermore that the adhesive layer has a clean, residue-free detachability after a long period of use.

Acrylate-based pressure sensitive adhesives are one type of adhesive suitable for use in this context. The advantages of such materials are their excellent adhesion, good tolerance to human skin components, low sensitization tendency and very good resistance to sterilization temperatures and aging.

Alternatively, the polymeric acrylate pressure sensitive adhesive may be used as an adhesive in combination with a plasticizing additive. The use of a plasticizing component in conjunction with the polymeric matrix ensures secure adhesion to human skin. However, the tendency of the plasticizing component to migrate must be taken into account here. As a result of the mixing of the two components with different adhesive properties, this can lead to non-uniform release properties from the skin.

A silicone adhesive may also be used to adhesively bond to the skin. Which has an advantage that it can be easily peeled off from the skin without damaging the skin even after being worn for a long time. However, adhesion and moisture permeability are reduced relative to acrylate-based pressure sensitive adhesives. Furthermore, the production of blocked adhesive layers with these pressure-sensitive adhesives is technically delicate.

In the medical, dermatological, cosmetic sectors, further alternative adhesives for adhesive bonding are represented by thermoplastic elastomers based on block copolymers with styrene-olefin-styrene blocks, tackifiers, generally also plasticizers and amphiphilic copolymers. It must be noted here that the migration of the plasticizer may impair not only the adhesion but also the appearance of the adhesive layer, but also that the adhesive has a blocking effect under certain circumstances, whereby the skin is hermetically sealed.

Adhesives suitable for the present purpose are in principle adhesives based on synthetic rubbers, in particular based on polyisobutylene, and preferably then, mixtures thereof with styrene-isoprene-styrene block copolymers and/or in the form of styrene-isobutylene-styrene block copolymers. Adhesives of this type may have additives, such as resins, added to them, in particular in order to enhance their adhesive properties.

Hydrogels are another class of adhesives for medical applications. It contains a high proportion of water and a natural high-molecular polymer, for example a polysaccharide, such as glucomannan, galactomannan, carrageenan, or sodium alginate, or other synthetic polymers which are frequently crosslinked for adhesion purposes, for example copolymers based on 2-acrylamido-2-methylpropanesulfonic acid.

Adhesives based on polyurethanes or polysiloxanes are other adhesives which can in principle be used for the purposes of the present invention.

In view of the stated requirements, and in particular also in view of the very low residual monomer content, the best adhesive types that have been found are pressure-sensitive adhesives comprising one or more polymers prepared from vinylic monomers and having a free monomer content of less than 0.01% by weight.

The breathability and thus the moisture vapor permeability (MVTR, moisture vapor transmission rate) of the adhesive system also become a decisive part in view of the long-term wear requirements and the durable good adhesion to the skin and the painless, residue-free detachment. This water vapor permeability can be determined in accordance with DIN EN 13726-2 at a temperature of 37 ℃ and an ambient humidity of 18%; or by the positive cup method according to ASTM E96 at a temperature of 23 ℃ with an ambient humidity of 50%.

Moisture permeability is accordingly understood to mean the rate at which moisture can pass through the membrane in the form of moisture per unit time. The higher the MVTR value, the better the effect, whereby moisture under the winding adjuvants can be avoided. The lack of breathability can lead to excessive wetness due to evaporation of the skin and thus a source of moisture, and thus, to some extent, skin softening, or promote undesirable adhesive layer separation processes. In conventional adhesive layer systems, which comprise a backing adhesive layer covering the adhesive layer before use and also a carrier material, it has hitherto been highlighted that the adhesive composition, the thickness of the adhesive layer or its structure, leads, for example, to a discontinuous application of the adhesive, which has been regarded as the primary determinant of the water vapor permeability of the overall system-while the carrier itself is a minor component. Thus, however, the carrier adhesive layer of the present invention is covered from both sides, and the construction of the carrier layer 30 gains significantly greater importance even in terms of the MVTR value of the overall system.

In order to adhere durably to the skin for a plurality of days, in particular for at least seven days in a reliable manner under all possible conditions, and at the same time still have a MVTR which allows the skin to breathe and which does not lead to detachment of the adhesive layer on ingress of moisture, the pressure-sensitive adhesive added should be at least 80 g/m². For economic and technical reasons, the upper limit is about 120 g/m². The pressure sensitive adhesive added is preferably 110 g/m². The resulting adhesive layer has an MVTR greater than about 400 g/m per 24 hours²。

The requirements desired for a pressure-sensitive adhesive for attachment to the skin also apply in principle to the material used for the carrier layer 30: even if the carrier material used in this case does not have any direct contact with the skin, the constituent parts of the carrier material may still migrate into and/or even through the adhesive layer and thereby come into contact with the skin. For this reason, the carrier material should also contain only skin-tolerable and minimally allergenic ingredients, if any. Further requirements include inherently contradictory expectations: on the one hand a certain flexibility/elasticity and on the other hand a certain rigidity. Flexibility and elasticity are required to accommodate irregular skin contours and to ensure that the material is attached even to moving skin, so as not to impede skin movement and to avoid creating a foreign body sensation. Rigidity is required to perform the mold cutting operation during manufacture and to ensure safe and quick attachment of the article to be worn.

Load bearing materials that in principle meet the above requirements may comprise, for example, a variety of polymer compositions that may be formed into low friction, elastic polymer sheets, for example from polyolefins such as polyethylene, polypropylene, or polybutylene terephthalate, from ethylene copolymers such as polyvinyl chloride, polyvinyl acetate, from paraffin copolymers, or additionally from acrylic polymers and copolymers. Blends or alloys of materials shaped to be plastically deformable or deformable and elastic, for example polypropylene and polyethylene, polyurethane and optionally polyolefins, polycarbonate or polyester, as pure TPE or TPU sheets, may likewise be used. The carrier layer 30 may take the form of a single or multi-layer sheet. It can be manufactured by conventional methods using sheet production, for example, by extrusion, co-extrusion, solvent casting, foaming.

Textile materials such as knitted or woven materials and also foamed materials, as well as combinations of the mentioned materials, can in principle also be used as starting material for the carrier layer 30.

The thickness of the carrier layer 30 may be in the range of 2 μm to 250 μm, having regard to inherently contradictory criteria regarding flexibility and rigidity. The carrier layer preferably has a thickness of less than 30 μm. The water vapor permeability of the support material should be at least 400 g/m in 24 hours²。

The sheet used as the carrier layer may be monolithic, provided that it exhibits the desired moisture permeability. However, the carrier layer may also be microporous or apertured to impart moisture vapor permeability to the non-moisture vapor permeable polymeric sheet. Sheets formed from the materials involved in principle have only very low MVTR values. To improve this, the sheets may be perforated to thereby obtain sufficient water vapor permeability. But the integrated even microporous thermoplastic sheet limits the MVTR of the skin side pressure sensitive adhesive to the area where the sheet is open due to the perforations; the purpose of suitable perforation should therefore be to provide as large a region of water vapour permeability as possible. On the other hand, the perforations should not negatively affect the rigidity required for the sheet-fixing device, and at the same time the adhesive added for the adhesive bonding of the structural type should only minimally, if at all, weaken the perforation openings at the side of the carrier sheet remote from the skin.

In view of the desired high MVTR rates, it is contemplated to use special microporous thermoplastic sheets with selectively different perforation geometries as the carrier material. Perforation geometries which are particularly suitable for this purpose are uniform or non-uniform (e.g. with some bulges) conical geometries, wherein the openings with the larger diameter should be on the skin-facing side, in order thereby to ensure a very large surface area for the penetration of water vapor from the skin-side adhesive layer and ideally at the same time prevent the penetration of adhesive into the openings remote from the skin side. Such larger openings may have a triangular, circular, or arbitrary polygonal shape. The perforations preferably have a truncated conical shape. It is also possible to use two or more perforations of different geometries in combination with each other in one sheet.

In order to improve the attachment of the adhesive to the plastic foil, the foil may be subjected to a suitable pretreatment, in the form of a pretreatment, for example a corona or plasma pretreatment, or the application of a suitable primer, or an etching treatment, before the adhesive is applied there.

To achieve good attachment of the adhesive to the carrier material, and high MVTR values, further alternatives include utilizing multiple layers of the carrier material, such as laminating a suitable material to the microporous sheet or co-extruding different materials into a single sheet and then microporous perforating. When laminated with another material, the plastic sheet has a water vapor permeability comparable to that of a fibrous nonwoven web or other fabric. Conventional lamination methods may be used, such as one involving heating, or one involving the use of an adhesive. Equally useful load bearing materials include plastic-coated fibrous materials in which at least the plastic coating layer is suitably perforated. The textile side of the textile constituting the carrier material can, depending on its suitability, be positioned not only on the skin-facing side of the carrier material, but also on its side remote from the skin.

In addition to the plastic foils or composite materials comprising plastic foils in question, pure textile carriers can also be used as the carrier layer 30. These fabrics may be utilized in the form of fibrous nonwoven webs or in the form of woven fabrics, in the form of stitches or in the form of circular knits; in principle, the form of the fiber bonds or bonds to one another can be freely selected. Starting materials for such fabric carriers may include natural or synthetic polymers, for example cellulose, silk or cotton as natural polymers, or polyvinyl chloride, polyurethane, polyester, polyamide, Nomex (Nomex), Kevlar (Kevlar), polypropylene, acrylic, Preox, nylon or rayon as synthetic polymers.

Woven or circular knitted polymer fibers with transverse elasticity have proven to be particularly advantageous in view of the expectations that the material of the carrier layer 30 needs to meet. These woven or circular knitted fibers derive their elasticity from the elasticity of the polyester yarn used. It should be noted that fibrous non-woven polyester webs with some micro-elasticity that may also be used herein are sufficiently flexible and elastic only in very thin form, but may not be easily die cut and fastened to an assembly platform. Woven and loop-knitted polyester fibers even in very thick applications (up to about 150 g/m)²) It is still sufficiently ductile to be applied as a carrier layer for the adhesive layer, while still having better cuttability, or more precisely, cuttability. The unidirectional cross-directional elasticity of the woven polyester fibers can be measured according to DIN 61632. The elasticity of the material used is advantageously less than 150%, preferably in the range from 20% to 80%, more preferably between 40% and 70%, ideally between 44% and 56%. Porosity of the support material (i.e. belonging to a small area within a particular reference zone)At about 400 μm²The proportion of pores) is in the range of 10% to 50%. The area of the associated aperture can be measured and calculated by measuring and calculating the aperture at some arbitrarily determined unstretched reference zone.

In the case of a woven fabric, the backing layer should have 300 to 350 warp threads, preferably 310 to 330 warp threads, and/or 100 to 140 weft threads, preferably 120 to 130 weft threads, per 10 cm of unstretched fabric.

Further components of the carrier system according to the invention are finally shaped by means of an assembly platform 20, which assembly platform 20 is structurally adhered to the skin-remote side of the carrier material and serves as a base plate for the diagnostic measuring instrument 12. The instrument 12 may, for example, guide a cannula that must be semi-implantably secured in and/or on the body. The combination of the load bearing layer 30 and the assembly platform 20 is exposed to severe mechanical stress for long periods of time due to the body's normal activities during the period of use and therefore must be structurally secure.

Structural adhesives that may be used for this purpose include epoxy adhesives, cyanoacrylate adhesives, and polyurethane adhesives. Cyanoacrylate adhesives are preferred: it is suitable and approved for biomedical engineering, it has very good adhesion to different materials, including to surfaces of low surface tension, it is particularly suitable for plastic-plastic bonding and plastic-metal bonding, it is a one-component system and therefore easy to handle, it is solvent-free and cures very quickly. Factors that affect the cure of cyanoacrylate adhesives include, among others, relative humidity and/or ambient temperature, the pH of the adhering surfaces, the materials to be bonded together, the width of the bondline, catalysts, the tackiness and cleanliness of the surfaces. This type of adhesive is particularly useful in applications requiring consistent pressure distribution, as well as high strength and shear strength.

UV-and moisture-curing cyanoacrylates have proven to be particularly advantageous because of their speed of cure and surface drying properties. Cyanoacrylates are based on "ethyl cyanoacrylates" and therefore find particular utility as structural adhesives for bonding plastics, metals and elastomers. The curing procedure is usually triggered by ambient humidity. In a relatively short timeFull functionality is achieved in-situ, while at least 24 hours are required for curing to the point of full medium resistance. At a temperature of 22 ℃ and a relative humidity of 50%, the adhesive reaches a bonding strength (shear strength 0.1N/mm) in a period of 3 seconds to not more than 300 seconds, depending on the material²). The rate of cure depends on the relative humidity. Lower humidity slows down curing and higher humidity promotes curing, but the ultimate strength of the adhesive bond is not impaired thereby.

When the curing rate is relatively slow due to a large joint, curing can be promoted by using a catalyst. But this may reduce the ultimate strength of the bond.

The present invention provides a carrier system for adhesive attachment to the skin further comprising a release liner 22, the release liner 22 covering the skin side of the adhesive layer prior to use. The adhesive area may be completely covered by a portion of the release liner, but it is also possible to use two or more liner strips, each strip only partially covering the adhesive portion, although it is in any case preferred to completely cover the adhesive area. Suitable materials for such release liners are siliconized paper, or alternatively adhesive coated plastic foils made of, for example, polyester, polyethylene terephthalate. In the case of siliconized release liners, the siliconization should comply with relevant food and pharmaceutical regulations.

The bearing system is manufactured by the following steps:

first, the adhesive layer 18 is carried as a cutting member, more precisely, produced as a die-cut member. For this purpose, the base material in the form of a flat product, in the form of a skin-adhesive layer, is cut longitudinally into narrow rolls. These rolls are processed continuously in a rotary die cutter, which is characterized by two rotary tools. A polyester liner 50 μm thick was laminated with the tack-free treated tape and cut in a first tool, thereby obtaining a grip sheet 24. The adhesive layer is then laminated in rows to the polyester liner by removing the original cover. In the second tool, the outer contour of the adhesive layer is initially cut and the unevenness is eliminated, and furthermore the positioning holes 28 are cut through. The registration control system is used simultaneously in the process. The product is then presented with a cover having a defined registration on the processing belt and can be further processed.

In a further step of the process, the die-cut parts are connected with the assembly platform 20. For this purpose, the assembly platform is first pretreated by applying a primer or hydrophilic agent before the adhesive bead of the medically approved moisture-curing cyanoacrylate adhesive. Cyanoacrylates with additional UV crosslinking over the reaction time are advantageous here. The VOC released by the adhesive is then pumped away by a suction device.

In a further step, the adhesive layer is dispensed by a dispenser onto the backing and temporarily stored and positioned there. The inversion-type repositioner then removes the adhesive layer and inverts it by approximately 180 degrees. A further repositioner removes the inverted adhesive layer and deposits it onto an assembly platform wetted with adhesive beads and laminates the adhesive layer onto the component parts. Optionally, the subsequent curing is accelerated from the backside by a UV LED area radiation system.

The thus obtained load bearing system is finally placed on the component part load bearing and then cured up to 24 hours in a storage unit with constant conditions (temperature, humidity) depending on the type of adhesive.

The system according to the invention can exemplarily be used for monitoring all possible types of body functions, such as blood glucose, GFR, blood pressure, EEG, heart rate, and in principle all types of clinical parameters, as a body inlet system for administration or feeding through a tube or pump system, as a body outlet system for a urine bag or abdominal wall attachment or as a carrying system for a body pendant in addition.

Claims

1. A carrier system for a body worn article (12) having a flexible carrier adhesive layer (18), comprising: a sheet-like carrier layer (30) and on its underside an adhesive layer (32), the adhesive layer (32) comprising a pressure-sensitive adhesive (34) and adhering to the skin (14) of the body part (16) by contact pressure, and an assembly platform (20) arranged on the upper side of the carrier layer (30) remote from the skin, wherein the carrier layer (30)30) Is attached evenly to a downwardly facing bonding surface of the assembly platform (20), characterized in that a bonding area (36) of the assembly platform (20) is firmly connected to the upper side of the carrier layer (30) by a structural adhesive bond (38) comprising a structural adhesive (40), and in that the adhesive layer (32) has a pressure sensitive adhesive application of 80 to 120 g/m²Wherein the carrier layer (30) comprises a microperforated thermoplastic sheet;

wherein the micro-perforations are conical and wherein the opening with the larger diameter is at the skin facing side.

2. The carrier system of claim 1 wherein a release liner (22) overlies the adhesive side of the adhesive layer (32) before the carrier adhesive layer (18) is attached.

3. The carrying system according to claim 2, wherein the release liner is removable by a protruding sheet (24).

4. Load carrying system according to any one of claims 1 to 3, characterized in that the load carrying layer (30) comprises a textile material or a foamed material or a combination thereof.

5. Load carrying system according to any one of claims 1 to 3, characterized in that the load carrying layer (30) has a maximum modulus of elasticity of less than 10N/mm²。

6. Load carrying system according to claim 5, characterized in that the load carrying layer (30) has a maximum modulus of elasticity of less than 5N/mm²。

7. The carrying system according to any one of claims 1 to 3, characterised in that the adhesive layer (32) has a pressure-sensitive adhesive application of 100 to 110 g/m²。

8. The carrying system according to any one of claims 1 to 3, characterized in that the adhesive layer (32) is formed from a pressure sensitive adhesive (34), the pressure sensitive adhesive (34) being based on acrylate, silicone, rubber, hydrogel, polyurethane, polysiloxane, vinyl acetate or mixtures thereof.

9. The carrying system according to any one of claims 1 to 3 wherein the carrying layer (30) carrying the adhesive layer (18) and/or the adhesive layer (32) has/have a viscosity of more than 400 g/m in 24 hours²Moisture permeability values of (a).

10. Load carrying system according to any one of claims 1-3, characterized in that the structural adhesive joint (38) comprises a structural adhesive (40) based on a cyanoacrylate adhesive, an epoxy adhesive or a polyurethane adhesive.

11. The carrying system according to any one of claims 1 to 3, characterized in that the pressure-sensitive adhesive (34) and the structural adhesive (40) have biocompatible components which are approved for medical use.

12. Load carrying system according to any one of claims 1-3, characterized in that the assembly platform (20) is shaped by plastic moulding.

13. The load carrying system of claim 12, wherein the assembly platform (20) is formed of polycarbonate.

14. The carrying system of claim 1 wherein the body worn article (12) is a medical device.

15. The carrying system according to any one of claims 1 to 3, wherein the carrying layer (30) comprises a sheet material.

16. Load carrying system according to one of the claims 1 to 3, characterized in that the adhesive layer (32) is shaped from a thermoplastic elastomer.

17. A method of manufacturing a carrying system for a body worn article (12) according to any of the preceding claims, comprising the steps of:

-providing a carrier-adhesive layer (18) comprising a carrier layer (30) and an adhesive layer (32), wherein the adhesive layer (32) has a pressure sensitive adhesive application of 80 to 120 g/m²，

-applying a structural adhesive (40) as an adhesive bead to the joining area (36) of the assembly platform (20),

-contacting the joining area (36) with the upper side of the carrier-adhesive layer (18) facing away from the skin to form a structural adhesive joint (38), wherein the upper side of the carrier layer (30) is attached flat to the downwardly facing joining area (36) of the assembly platform (20).

18. A method as claimed in claim 17, characterized in that the carrier adhesive layer (18) is a die-cut part.

19. A method according to claim 17, wherein the structural adhesive (40) presses the load-bearing adhesive layer (18) against the assembly platform (20) during curing.

20. The method according to any one of claims 17 to 19, wherein the structural adhesive (40) is cured in a reinforcing manner.

21. The method of claim 20, wherein the structural adhesive (40) is cured by radiation.

22. A method as claimed in claim 17, wherein the carrier adhesive layer (18) further comprises a release liner (22).